European Medicines Agency workshop on extrapolation across age groups

EventCorporateMedicines

Date: Wednesday, 30 September 2015, All day
Location: European Medicines Agency, Amsterdam, the Netherlands

The primary rationale for extrapolation is to avoid unnecessary studies in the target population for ethical reasons, for efficiency, and to allocate resources to areas where studies are most needed. In situations where the feasibility of studies is restricted, extrapolation principles may be applied for rational interpretation of the limited evidence in the target population in the context of data from other sources. As per the published European Medicines Agency (EMA) concept paper on extrapolation of efficacy and safety in medicine development, EMA is developing a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. With the aim of developing the regulatory framework the Agency is holding an EMA experts workshop on 30 September. This workshop aims to bring together experts from the European medicines regulatory network. Registration by invitation only.

Documents

Agenda - Medicines Agency workshop on extrapolation across age groups

Reference Number: EMA/462579/2015

English (EN) (88.61 KB - PDF)

First published: 14/07/2015Last updated: 09/12/2015

Presentation - Extrapolation framework: status quo and issues to be resolved (C. Male)

English (EN) (999.29 KB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - When do clinicians usually extrapolate in their practice? (D. Brasseur)

English (EN) (1.64 MB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - Extrapolation for antiepileptic drugs (AED) in paediatrics (G. Pons, C. Chiron)

English (EN) (124.03 KB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - Modellers perspectives: how modelling and simulation can address gaps in knowledge (I. Skottheim Rusten)

English (EN) (259.64 KB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - Statisticians perspectives on extrapolation (D. Wright)

English (EN) (134.99 KB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - What should be the source data when considering a paediatric development (S. Cole)

Summary:

EMA extrapolation workshop 30 September 2015

English (EN) (697.41 KB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - Paediatric extrapolation in FDA submissions: sources of data (G. Burckart)

English (EN) (560.65 KB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - How to weigh the strength of prior information and clarify the expected level of evidence? (M. Posch)

English (EN) (1.21 MB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - Dealing with risk and uncertainties (A. Nordmark, N. Benda)

English (EN) (66.49 KB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - Extrapolation in antibacterial agents (I. Lutsar, M. Fernandez Cortizo)

English (EN) (582.75 KB - PDF)

First published: 09/12/2015Last updated: 09/12/2015

Presentation - The role of modelling/simulation in paediatric population (J. Karres, N. Benda, J. Standing)

English (EN) (401.76 KB - PDF)

First published: 09/12/2015Last updated: 09/12/2015